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Regulatory News | 01 August 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics.
To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving implementation across all FDA offices by the end of Q2 2017.
In 2014, after an industry survey highlighted concerns over communication and coordination issues during intercenter consults for combination products, FDA's Office of Planning (OPL) launched a study into how to improve the coordination and communication around combination products.
Specifically, the study aimed to look into "management, timing, timeliness, and workload challenges" related to intercenter consults. FDA staff also sought input from two industry groups, the Combination Products Coalition (CPC) and the Advanced Medical Technology Association (AdvaMed), on issues industry faces from such intercenter consults.
After receiving input, the study team held a series of focus groups with staff from the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) and conducted 18 interviews with FDA staff to identify four main issues: different policies, practices and application types; separate review and tracking systems between centers; unclear communication channels between centers; and a lack of resources to review consults.
The study team then issued five recommendations, which FDA Commissioner Robert Califf endorsed, for the agency to improve combo product reviews:
The recommendations came as FDA continues to delay the finalization of a rulemaking on the postmarket safety reporting for combination products, which was first proposed in 2009 and slated for final release in May, but has yet to materialize.
Michael Rappel, a senior science advisor in CDER, and Rachel Sherman, FDA’s associate deputy commissioner for medical products and tobacco, wrote in a blog post on Monday that FDA will conduct its intercenter pilot in three phases, the first and second of which will be used to help refine the initial steps of the ICCR process (e.g., consult request, ICCR form, reviewer assignment) though they say that “some limited consult completion data (e.g., consult quality and timeliness) available for Investigational Device Exemptions/Investigational New Drugs may provide initial insights on consult closeout.”
The pilot will aim to address four improvements targeted at the review team's recommendations:
“During each phase of implementation, we will collect quantitative and qualitative data to evaluate success,” Rappel and Sherman write. “What we learn at each stage will allow us to refine processes, procedures, and training for subsequent phases. In particular, data from phases 1 and 2 consult completion data for other submission types will also be collected but may not be available for several months due to the longer submission review timelines.”
For those with feedback or input on the pilot, Rapel and Sherman are available at: combinationproductICCRpilot@fda.hhs.gov.
Tags: combo products, drug and device combination product, FDA pilot project